BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN SCD

    MDR report key: 1920584 · Received December 7, 2010

    Report

    Report Number
    1017072-2010-00040
    Event Type
    Other
    Date Received
    December 7, 2010
    Report Date
    November 16, 2010
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/7/2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A SCD EXPRESS SLEEVE. THE CUSTOMER REPORTS THE PT HAD LOWER EXTREMITY ECCHYMOSIS WHICH IS PURPLE IN COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SCD SCD EXPRESS SLEEVE JOW COVIDIEN UNK SCD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other